U.S. FDA Adverse Event Reporting & Contact Services
With simple, customizable technology for adverse event reporting and access to experienced Regulatory Specialists, Registrar Corp makes it quick and easy for businesses to comply with FDA’s adverse event regulations.
Keep FDA from considering your products “Misbranded”
FDA considers an adverse event as any untoward medical occurrence associated with the use of a cosmetic, dietary supplement, or medical device. Records collected from adverse event reporting represent critically important safety information for the public and must be reported to FDA as soon as possible.
Failure to collect and report adverse events to FDA in a timely manner earns your products a ban on entry to the United States.
With Registrar Corp’s comprehensive Adverse Event Reporting services, we’ll collect adverse event reports for you so you can keep your product moving in the right direction.
Cosmetic Adverse Events
Gain compliance with FDA’s Modernization of Cosmetics Regulation Act (MoCRA).
Due to this historic change in the U.S. cosmetic industry, cosmetic companies are now required to collect, maintain, and submit reports on adverse events to FDA. Depending on your individual needs, we can either assist you in meeting basic compliance or fully handle the collection and timely reporting of your adverse events.
Medical Device Adverse Events
Medical device adverse event reporting is essential for helping mitigate device-related risks to the public. To address and prevent future harm to patients, adverse events involving medical devices must be reported to the U.S. FDA for formal investigation.
Adverse Events For Dietary Supplements
Since 2007, manufacturers and label distributors of dietary supplement products are required to report adverse events for finished dietary supplements, along with a copy of the product’s label to FDA. Registrar Corp can help collect adverse event reports from consumers.
